NCT04259320 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Buck ML, Amir LH, Cullinane M, Donath SM; CASTLE Study Team
Nipple pain, damage, and vasospasm in the first 8 weeks postpartum. Breastfeed Med. 2014 Mar;9(2):56-62. doi: 10.1089/bfm.2013.0106. Epub 2013 Dec 31.
Dennis CL, Jackson K, Watson J
Interventions for treating painful nipples among breastfeeding women. Cochrane Database Syst Rev. 2014 Dec 15;(12):CD007366. doi: 10.1002/14651858.CD007366.pub2. Review.
Puapornpong P, Paritakul P, Suksamarnwong M, Srisuwan S, Ketsuwan S
Nipple Pain Incidence, the Predisposing Factors, the Recovery Period After Care Management, and the Exclusive Breastfeeding Outcome. Breastfeed Med. 2017 Apr;12:169-173. doi: 10.1089/bfm.2016.0194. Epub 2017 Mar 9.

Effect of the Use of Beeswax-containing Barrier on the Prevention of Nipple Crack in Lactating Primiparous Women Within the First 24 Hours After Giving the Birth: A Randomized Controlled Trial

Details for clinical trial NCT04259320

Clinical trial NCT04259320 - References